The present invention relates to the sterile and total containment welding techniques for fluid filled plastic tubes that control bacterial necrosis through rheological dynamics.
Prior patents such as our U.S. Pat. No. 4,793,880 and U.S. Pat. Nos. 4,610,670 and 4,369,779 by co-inventor Dudley W. Spencer disclose processes that once the process starts, have no control of the interrelated series of events leading to a sterile connection. For example, no attempt is made, other than setting the upper temperature limit of the cutting means, to control the welding process to guarantee sterility each time a weld is made. Variables such as
Temperature drop of the blade from cutting the plastic or fluids PA0 Plastic Rheology PA0 Debri control PA0 Weld strength PA0 Pin holes within the joint PA0 Lumen occlusion PA0 Bacterial Morphology & necrosis PA0 Plastic rheology PA0 Bacteria necrosis PA0 Debri control PA0 Lumen occlusion PA0 Weld strength
are all out of control during the critical phases of process dynamics. Moreover, the processes leave two leaky stub ends that are unacceptable for handling dangerous fluids.
Our U.S. Pat. No. 4,753,697 solved the leaky stub-end problem, but no attempt was made to gain control of the process dynamics.